Diosmektit (Powder) Instructions for Use

Marketing Authorization Holder

Pharmacor Production, LLC (Russia)

ATC Code

A07BC05 (Diosmectite)

Active Substance

Diosmectite (Ph.Eur. European Pharmacopoeia)

Dosage Form

Diosmectite

Powder for oral suspension 3 g: sachet 5, 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

3 g – sachets (5) – carton packs.
3 g – sachets (10) – carton packs.
3 g – sachets (20) – carton packs.
3 g – sachets (30) – carton packs.

Clinical-Pharmacological Group

Antidiarrheal drug with adsorbent action

Pharmacotherapeutic Group

Antidiarrheal agent

Pharmacological Action

An adsorbent and antidiarrheal agent of natural origin. It has a protective effect on the intestinal mucosa, possesses a pronounced adsorbent and a mild enveloping action.

It is a stabilizer of the mucous barrier, penetrates into the mucus and increases its lifespan, forming a physical barrier that protects the mucous membrane of the digestive tract from the negative effects of H⁺ ions, intestinal microorganisms and their toxins.

Pharmacokinetics

Not absorbed, excreted unchanged.

Indications

Acute and chronic diarrhea (of allergic, drug-induced origin; due to dietary regimen violations and qualitative composition of food), diarrhea of infectious origin – as part of complex therapy.

Treatment of symptoms associated with diseases of the stomach and intestines: heartburn, feeling of heaviness, bloating, abdominal discomfort and other symptoms of dyspepsia.

ICD codes

Dosage Regimen

Administer orally. Prepare the suspension immediately before use by emptying the contents of one sachet into approximately 50 mL (1/4 cup) of water. Stir until a uniform suspension forms.

For acute diarrhea in adults, the standard daily dosage is 3 sachets (9 g). Initiate treatment with 2 sachets for the first dose, followed by 1 sachet for subsequent doses.

For children aged 1 year and older with acute diarrhea, the standard daily dosage is 2-3 sachets. For infants under 1 year, the standard daily dosage is 1 sachet. Continue treatment for 3 days; if symptoms persist, consult a physician.

For other indications such as heartburn, bloating, or abdominal discomfort in adults and adolescents over 12 years, the standard dosage is 3 sachets per day.

For children aged 2 to 12 years for these indications, the standard daily dosage is 2-3 sachets. For infants under 2 years, the standard daily dosage is 1-2 sachets.

For ease of administration in children, mix the prepared suspension with a semi-liquid food such as porridge, puree, or compote.

Maintain an interval of 1-2 hours between the administration of Diosmectite and any other medicinal products to avoid impaired absorption.

In cases of acute diarrhea, initiate oral rehydration therapy concurrently to prevent dehydration. Adjust the total fluid intake based on clinical presentation and patient age.

Adverse Reactions

From the digestive system:often – constipation; infrequently – flatulence, vomiting.

Allergic reactions frequency unknown – urticaria, rash, itching and angioedema.

Contraindications

Hypersensitivity to diosmectite; intestinal obstruction.

With caution in patients with severe chronic constipation.

Use in Pregnancy and Lactation

Can be used during pregnancy and breastfeeding according to indications, in recommended doses.

Pediatric Use

In children, use according to indications, in recommended doses, in appropriate dosage forms.

When used in children under 12 years of age, the drug in the appropriate dosage form can be dissolved in liquid or mixed with a semi-liquid food (porridge, puree, baby food).

Special Precautions

The interval between taking diosmectite and other medicines should be 1-2 hours.

In children with acute diarrhea, Diosmectite should be used in combination with rehydration measures. If necessary, adults may also be prescribed diosmectite therapy in combination with rehydration measures. The complex of rehydration measures is prescribed depending on the course of the disease, age and characteristics of the patient.

Drug Interactions

When taken concomitantly orally, Diosmectite reduces the rate and/or extent of absorption of other drugs.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.